Study on the function and the responsibilities of ethics committees in Japan

越来越多的伦理委员会（ECs）表明，日本临床环境中的决策过程发生了重大变化。本研究的目的是：1)调查现状；2)制定在综合医院环境中建立和运行EC的指导方针；3)探讨选委会的自由裁量权和责任程度；4)提出全面建议。为了达到上述目标，我们进行了几次调查。1)综合医院（1996年）。向3 098家综合医院的院长发送了一份自行填写的问卷（治愈率：44%）。约15%的人患有ECs。他们面临的问题是职责不明确、财务问题和没有统一的决策标准。2)医学院（1995-1996年）。向所有80所医学院的EC发送了一份自我管理的问卷，询问其现状（恢复率：100%）。超过一半的人回答说，将独立于学术团体和部门进行研究。3)学术团体（1998）。向137个学会理事发送自填问卷（回收率88%）。28个社团有共同体。大多数社会团体回答说，当他们的意见与医学院的决定相冲突时，他们不会干预，只会提出反对意见。4)保健福利部（1999年）。与两名参与政策制定的官员进行了半结构化访谈。对于器官移植等已合法化的问题，卫生部基本上是进行规范和干预的。其他问题则逐案处理。最后，对于“日本的欧共体制度是否独特”这个问题，我们的回答是，在成员构成、地点、讨论的议题等方面，似乎与其他国家的欧共体制度相似。这种差异可能不在于前景，而在于寻求共识倾向等决策程序，需要进一步分析。

The growing number of ethics committees (ECs) indicates that significant changes have occurred in the decision making process in the clinical setting in Japan. The purposes of this study are to : 1) investigate the current status ; 2) make guidelines for establishing and running an EC in a general hospital setting ; 3) to explore the degree of discretion and responsibility of the EC, and 4) to make a comprehensive proposal. To achieve the above goals, several surveys were conducted.1) General hospitals (1996). A self-administered questionnaire was sent to directors of 3,098 general hospitals (recovery rate: 44%). About 15% had ECs. The problems they faced were unclearness of their responsibilities , financial issues , and no uniform decision making criteria.2) Medical schools (1995-1996). A self-administered questionnaire was sent to the EC of all 80 medical schools, asking about the current status (recovery rate: 100%). More than half of them answered that they would review issues independently from academic societies and ministries.3) Academic societies (1998). A self-administered questionnaire was sent to directors of 137 societies (recovery rate: 88%). Twenty-eight societies had ECs. Most societies answered that they would not intervene but just make objections when their opinions conflicted with medical schools' decisions.4) The Ministry of Health and Welfare (1999). Semi-structured interviews were performed with two officers who were engaged in policy making. The Ministry basically regulates and intervenes in the issues that are legalized such as organ transplantation. Other issues are handled case by case.Finally, for the question "Is the Japanese EC system unique?", we would answer that factors such as member constitution, location, and topics discussed seem to be similar to ones in other countries . Rather than the outlook, the difference might exist in its decision making procedures such as a consensus-seeking tendency, and needs further analysis.